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The Effect of Animated Videos and Therapeutic Play Methods on Emotional Expression, Fear and Anxiety in Children Aged 4-8 Years During the Throat Swab Procedure

No phase Interventional Taking a Throat Swab

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Animation video, Therapeutic Play.
Who it may be relevant to
Registry conditions: Taking a Throat Swab. Basic parameters: 4 years — 8 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Effect of Animated Videos and Therapeutic Play Methods on Emotional Expression, Fear and Anxiety in Children Aged 4-8 Years During the Throat Swab Procedure: A Randomised Controlled Trial

Overview

We planned a study to determine the effect of showing an animated video and using educational therapeutic play methods prior to throat swab procedures in children aged 4-8 years on the children's compliance with the procedure, as well as on their emotional expression, fear and anxiety levels, and to compare the superiority/effectiveness of these two methods against one another. The sample size for the study was determined using an a priori power analysis conducted with the G\*Power (v3.1.9.7) programme. It is planned to include a total of 105 children, with at least 35 children in each group. The study will be conducted using a single-blind, parallel-group, three-group experimental design. By demonstrating the effects of two different modern approaches on children's compliance, fear, anxiety and emotional responses during the throat swab procedure, this study will contribute to the development of evidence-based, atraumatic care practices in paediatric clinics.

Detailed description

Hospital visits during childhood and the diagnostic and medical procedures carried out during these visits cause high levels of fear, anxiety and stress in children. The throat swab procedure, frequently used in the differential diagnosis of upper respiratory tract infections, is perceived by children as a threatening and invasive procedure due to the physical contact with the pharynx and the triggering of the gag reflex (Sajeev et al., 2021). Children aged 4-8, due to their developmental characteristics, may struggle to comprehend abstract concepts and may therefore interpret such procedures as punishment or an attack on their bodily integrity (Vakili et al., 2025). The intense anxiety and fear experienced during the procedure make it difficult for children to comply with treatment, leading to negative emotional expressions such as crying and resistance, and undermining the future healthcare professional-patient relationship (Şengül \& Erkut, 2025).

In paediatric nursing and the philosophy of atraumatic care, minimising the psychological and physiological trauma children experience as a result of medical procedures is one of the primary objectives. The literature indicates that audiovisual distraction techniques using animated videos to reduce children's anxiety and fears, and instructional therapeutic play-which helps children learn by making the steps of a process tangible-are effective non-pharmacological methods (Suleiman-Martos et al., 2022; Altay et al., 2025). However, there are few randomised controlled trials directly comparing the effectiveness of the 'instructional animation video' method with that of 'therapeutic play'-which enables the child to experience the process and gain a sense of control-in a procedure such as a throat swab, which is sudden and highly uncomfortable.

This study will contribute to the development of evidence-based, atraumatic care practices in paediatric clinics by demonstrating the effect of two different modern approaches on children's compliance, fear, anxiety and emotional responses during the throat swab procedure.

Research Hypotheses:

H0: There is no difference in the levels of emotional expression, fear and anxiety among children who undergo the throat swab procedure following the use of animated videos and therapeutic play methods.

he study will utilise the Children's Emotional Expression Assessment Scale ,the Children's Fear Scale, the Children's Fear Scale.

The animation and therapeutic game (playing cards) to be created for the intervention group will be developed by the researchers and implemented following consultation with experts.

Randomisation: In the study, patients meeting the inclusion criteria will be allocated to groups using a simple randomisation method (randomizer.org) to the animation video and therapeutic game (game cards) groups. The allocation of groups will be concealed using sequentially numbered opaque envelopes. The study will be conducted as a single-blind trial during the data analysis phase. Descriptive data will be analysed using frequency, percentage, mean, standard deviation, minimum and maximum values. In the analysis of comparative data between the case and control groups, parametric or non-parametric tests will be used, depending on whether the data follow a normal distribution.

Interventions

  • Other Animation video
    The animated video will be produced as a short video explaining the process carried out by the researchers.
  • Other Therapeutic Play
    Therapeutic play will be planned to incorporate elements of gamification. The child will be encouraged to carry out the activity using a toy.

Primary outcome measures

  • Changes in children's scores on scales measuring anxiety, fear and emotional expression before and after the intervention [Time frame: Before İntervention and after procedure(throat swab)]

Eligibility criteria

Inclusion criteria

Children whose parents have provided written informed consent, who have had a throat swab taken at a paediatric clinic, who have verbally agreed to participate in the study, aged between 4 and 8 years, with no cognitive or neurological differences, with no visual or hearing impairment.

Exclusion criteria

Children whose parents have not provided written informed consent, who have not had a throat swab taken at a paediatric clinic, who have not verbally agreed to participate in the study, younger than 4 years or older than 8 years, with cognitive or neurological differences, with visual or hearing impairment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • Mersin University — Mersin

Identifiers

NCT: NCT07693842 · SKaya_003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗